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12/18/2020

Industry Updates - Volume 2

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Volume 2 of our Industry Updates sees the second Covid-19 wave still raging and highlights the latest vaccine developments.

Pandemic Stats Update

Second COVID-19 Wave Still Raging

Pandemic data shows strong growth in the frequency (# of infections) and severity (# of deaths) of COVID-19 - both Globally and in the U.S. - from Mid-November to Mid-December:
- # of infections grew 26% around-the-world and 38% in the U.S.
- # of deaths grew 20% around-the-world and also 20% in the U.S.
Surprising growth rates in the last month, on a large base of infections/deaths.

Industry News

Pfizer/BioNTech Vaccine Rollout/Allergic Reactions

Following the granting of Emergency Use Authorizations (EUA) in both the UK and U.S., two severe allergic reactions occurred in the UK, followed by two allergic reactions in Alaska. One severe case of anaphylaxis occurred in Alaska for a person with no history of allergies.

Moderna Approval

Moderna reports 95% efficacy from 14 days after the 2nd shot as the headline, with equal effectiveness across genders, ethnic groups. In the 65 and older group, efficacy fell to 84%.
More severe reactions to first/second Moderna shots than in Pfizer's case. 19% of the placebo group suffered pains from the shot, 84% of the vaccinated group suffered. Of these, one in five (16% overall) had 3rd level severity - i.e., unable to carry on daily activities, going to work and/or needed prescription-only level painkillers. 10+ times the level of the placebo group.
As with Pfizer, a number of cases of Bell's Palsy occurred in vaccinated groups, and in addition, facial swelling in people with dermal injections.
Eleven vaccinated persons got Covid-19 - not severely. One vaccinated person died.
FDA Advisory Committee voted 20-0 (with abstention of the industry rep) to recommend EUA for Moderna from FDA. (Pfizer had four votes against).

Astra Zeneca/Sputnik Discussions

Following the 62% efficacy result for the core Oxford 2 shot design, discussions commenced with Russian vaccine Sputnik, which has a better design - it uses a different adenovirus for the first/second shots (addressing the problem of adenovirus not working the second time).
The Russian vaccine was criticised for inadequate testing and may have manufacturing challenges, which Astra Zeneca could help overcome.

CSL/University of Queensland’s Protein Sub-Unit Based Vaccine Cancelled

Vaccine was promising, with novel technology used to bind spike protein derived from HIV, but it caused false positive HIV results in testing.

Sanofi/GSK Delayed

Following mistakes in the calibration of the level of antigens in their vaccine candidate - leading to poor results - a new formulation and trial is contemplated, prompting a delay of 6-7 months. Could lead to final approval by the end of 2021, vs. original plan to gain approval in May, 2021.

Johnson & Johnson (J&J) One-Shot Adenovirus Vaccine Now up to 45,000 Stage 3 Trial Participants

J&J is expected to report initial results from this Trial in late January, after a one-week delay due to an ‘unexplained illness’.
Two-Shot version is also being tested in Stage 3 Trials by J&J/Janssen.

Valneva Whole Inactivated Virus (WIV) Vaccine Enters Trials

Valneva just commenced Stage 1 Trials in the UK for their WIV vaccine, that would be primarily focused on the UK/Europe once approved.

Finance News

Novavax Executives Sell Shares

The top five executives of Novavax all sold approximately U.S. $5M of shares each at prices of U.S. ~$120 per share over the past eight weeks; 30% below the U.S. $180 peak in August.
Investment analysts suggest this indicates a lack of confidence in their Protein Sub-Unit vaccine.

Gates Provides Funding for Second Wave Covid-19 Vaccines

The Gates Foundation together with Coalition for Epidemic Preparedness Innovations (CEPI) announced their first investment in a next-generation 'Wave 2' vaccine candidate for Covid-19, making a U.S. $10M grant to SK Bioscience of South Korea.

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12/11/2020

Industry Updates - Volume 1

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Welcome to our first Industry Update, which brings you the latest news in Covid-19 Vaccine Developments and Industry Financial Updates.

Covid-19 Vaccine Developments

Pfizer/BioNTech (Pfizer) achieved Emergency Use Authorization (EUA) in the UK and Canada, and EUA appears imminent in the US.
The Pfizer submission to the FDA reveals a significant issue with side effects during vaccinations. This was mirrored during the very first day of administering the vaccine in the UK, where two health workers suffered anaphylaxis - a very serious and life threatening allergic reaction, leading to a recommendation from the MHRA to stop giving the vaccine to allergic people and to only administer this vaccine in a hospital or clinical setting.
In Stage 3 Trials of the Pfizer vaccine, vaccine recipients suffered 2X-10X more side effects than placebo recipients, including fever, headaches and fatigue, many lasting several days. There were also unexplained increases in lymphadenopathy, Bell's Palsy, and appendicitis among the vaccinated group.
In dramatic contrast to Pfizer, almost the same percentage of parties injected with the Sinovac Whole Inactivated Virus (WIV) vaccine (19%) or placebo (18%) complained, mostly of local pain at the site of the injection only.
The 94% 'headline' efficacy rate for the Pfizer vaccine – which has been widely publicized – is based on measuring those people who had received both doses and after a further time lapse to allow the immunity to become stronger. The raw data however of the full group was 50 vaccinated persons who got COVID-19 compared to 275 on the placebo, which is 82% efficacy. There were four deaths from COVID-19, one among the vaccinated and three among the placebo (66% efficacy). Efficacy against severe Covid-19 disease was measured at 75% (one vaccinated party vs four on placebo).
Pfizer is the most difficult vaccine to administer, not just because of the -70°C cold chain distribution requirement, but also because it needs to be thawed and diluted 3-to-2 with sterile Sodium Chloride 0.9% injection just prior to vaccination; this creates five doses, which then all must be used within 6 hours from the time of dilution.

The Astra Zeneca/Oxford adenovirus-based vaccine received pushback from the FDA and the Indian regulators, following problems with the trials and poor disclosure; nonetheless, it is likely to be approved in the UK next month.
The leading WIV contenders, Sinopharm and Sinovac, which received Emergency Use Approval in China in July 2020, have now vaccinated 1.3 million people in a dozen countries, 5X more than all other vaccines in development world-wide. No reports of serious side effects so far. Use authorizations given in Bahrain and the UAE, imminent in Indonesia. Efficacy of 84% is suggested from a small sample – more extensive results expected from multi-country Stage 3 Trials in weeks.

Industry Financial Valuation Updates

The pure-play Biotech mRNA stock prices have risen by more than 3x in six months. Moderna is now valued at U.S. $61B; BioNTech (which shares the rights 50/50 with Pfizer) at U.S. $31B; the German Curevac at U.S. $23B.
Sinovac raised U.S. $515M for 15% ownership this week valuing the Covid-19 vaccine unit at U.S. $3.4B. This followed the successful completion of Sinovac’s Stage 2 Trials and the commencement of Stage 3. Seven months ago, on completing the animal trials and starting Stage 1 in humans, the company sold 15% for U.S. $15M or a valuation of U.S. $100M. This represents a 34X gain in 7 months.

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Industry Updates - Volume 2

Industry Updates - Volume 1

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